Gish RG1, Wadler S1.
J Clin Oncol. 2004 Jul 15;22(14_suppl):4260.4260 Background: We compare the patients' safety profile in the Phase III ETHECC (E) trial to the combined patient safety profile of patients treated with nolatrexed dihydrochloride (THYMITAQ) (T) in the 3 uHCC Phase II studies. T is a folate analogue inhibitor of Thymidylate Synthase (TS) that binds directly to the folate site of TS.METHODS: The hematological (H) toxicities (anemia, neutropenia, and thrombocytopenia) and non-hematological (NH) toxicities (mucositis, nausea, vomiting, diarrhea, and rash) data are compared between 117 T patients from the E trial (following the second independent Data Safety Monitoring Board [DSMB] in May 2003) and 129 T patients from the Phase II studies in HCC (Studies 008 [Stuart et al]; 014 [Mok et al]; 015 [ASCO 2003]). Read More